Philips Ingenia Ambition X MRI System Alignment Error in Image Review
Philips is recalling 300 Ingenia Ambition X MRI systems due to potential alignment errors in the cross-reference line functionality when reviewing images with the MobiView application. This error could affect diagnostic accuracy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a diagnostic imaging system with potential for alignment errors that could affect clinical decision-making. With no reported injuries or illnesses and the hazard being a risk-of-harm scenario, this meets the Score 3 (High) criterion.
Plain-English summary
Philips North America LLC is recalling 300 units of the Ingenia Ambition X MRI system (models 781356, 782109, and 782138). The recall affects 81 units distributed in the United States and 219 units distributed internationally across multiple countries.
The systems have a potential for alignment errors in the cross-reference line functionality when reviewing images generated with the MobiView application. These alignment errors could affect the accuracy of image review and clinical interpretation.
Healthcare facilities using affected units should contact Philips regarding corrective actions. Consumers and healthcare providers should verify their equipment model numbers and serial numbers against the recall list to determine if their systems are affected.
The recalled product
- Product
- Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
- Manufacturer
- Philips North America Llc
- Hazard
- alignment-error
- diagnostic-inaccuracy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Numbers: (1) 781356
- (2) 782109
- (3) 782138
- UDI-DI: (1) 00884838090040
- (2) 00884838098350
- (3) 00884838108622
- Serial Numbers: (1) 47002
- 47004
- 47011
- 47012
- 47018
- 47019
- 47020
- 47028
- 47029
- 47037
- 47049
- 47052
- 47057
- 47099
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03